Senior Quality Engineer

vor 2 Monaten

Winterthur Zurich Switzerland Zimmer Biomet Vollzeit

Job description:

Quality Sr Engineer is responsible for Quality Engineering activities related to existing, introduction of new or improved products and processes into the manufacturing site, nonconformance management, and interactions with all plant functions to achieve goals and provide required manufacturing support. These includes quality assurance activities required for New Product lnitiatives (NPl), Transfer projects, Receiving, ln-Process and Finished Device Acceptance to ensure that the manufacture and distribution of medical products is in compliance with company policies and procedures, U.S. Food and Drug Administration (FDA)QSR 820 regulations, ISO 13485, ISO 14971 and the Medical Device Directive (MDD 93142 ECC) and Medical Device Regulation (MDR 20171745).

How You'll Create Impact
Participate as subject matter expert in audits by FDA, Notified Bodies, internal audit program, etc.
Ensure that Design Control and Post Market Engineering requirements are applied to Product and Process Changes and New Product lnitiatives

  • Ensure that the process for design transfer consistently meets requirements according to site procedures and regulations
  • Leads quality projects according to project plan
  • Ensure effective handling of risk based sampling plans for purchased, incoming, in-process, final product inspection to assure that designed product and processes comply to specifications
  • Support review and release of validation activities
  • Support review and release for measurement system analysis, Test Method Validation, Gage R&R
  • Ensure NCR support for internal produced products
  • Drives and supports continuing improvement projects in the area of responsibility

Required profile:

At least 3 years of practical experience in the medical device industry or other regulated industry (implantable devices experience preferred)

  • Demonstrated knowledge of FDA regulations QSR 820, ISO 13485, Medical Device Directive Regulation (MDD 93/42EEC) and Medical Device Regulation (MDR 20171745)
  • Solid background for reguired Quality Assurance activities for Design Control and Transfer activities e Proven records of successfully closed projects preferable for NPl, Design Transfer or Optimization Projects with medium to high business impact
  • Experience in cross functional collaboration is an asset
  • Demonstrated knowledge in project management Special expertise
  • Deep background in general quality assurance activities e.g. lnspection planning, NCR-handling, validation assurance
  • Good background in statistical test methods to prove quality assurance (e.g. MSA, capability studies, AQL, test methods)
  • Deep knowledge in the handling of the SAP QM system . Deep knowledge on all Quality Assurance processes in the area of responsibility
  • Effective use of Microsoft Office Tools for evaluation, reporting and presenting Languages
  • Good English skills (written/oral)
  • Good German skills (written/oral)

What we offer:

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

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